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a Multicentre Phase III Study of Risk-based Treatment Intensification With Hyperfractionated Radiotherapy in Head and Neck Cancer Patients

Phase 3
Recruiting
Conditions
Head and Neck Squamous Cell Carcinoma
Interventions
Radiation: Control group
Radiation: Hyperfractionated radiotherpy
Registration Number
NCT06248996
Lead Sponsor
Lund University Hospital
Brief Summary

There is an unmet need to personalise treatment for patients with head and neck squamous cell carcinoma (HNSCC) and to improve treatment results for patients with advanced disease. In this phase III study, HNSCC patients with prognostic factors indicating increased risk of treatment failure that are aimed for curative treatment with radiotherapy (RT) will be randomised between standard treatment (conventionally fractionated RT with final RT dose 68.0 Gy) and hyperfractionated RT (HFX-RT) with final RT dose 83.0 Gy.

In order to find better prognostic and predictive tools the study also includes exploratory and translational analyses including evaluation of grade of hypoxia with Magnetic Resonance Imaging (MRI) and gene profiling by RNA-sequencing, tumour immune profiling, comparisons of global gene expression, gene aberrations and protein expression, and texture analyses of CT, FDG-PET and MRI images used during RT preparation and during patient follow-up. Patients with tumours with lower risk of recurrence, not eligible for randomisation in the study, can still participate in the translational parts of the study not investigating response to altered fractionation.

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
308
Inclusion Criteria
  1. The patient must be at least 18 years old.

  2. Histologically or cytologically confirmed, previously untreated, HNSCC of the oropharynx, hypopharynx, larynx or oral cavity without distant metastases and aimed for treatment with radiotherapy (with or without concomitant chemotherapy) with curative intent.

  3. The primary tumour must fulfil the following high-risk criteria:

    1. For p16+ oropharyngeal cancer: Radiographic measurement of threeorthogonal diameters must render a tumour estimate of ≥30 cc.
    2. For all other subsites and for p16- oropharyngeal cancer: Radiographic measurement of three orthogonal diameters must render a tumour estimate of ≥20 cc.
  4. The treatment may be followed but not preceded by surgery, either as a salvage procedure or a neck dissection. An excision of a lymph node or tonsillectomy for diagnostic purposes, does not exclude the patient from participation.

  5. WHO/ECOG performance status 0-2

  6. The patient must be able to understand the information about the treatment and give a written informed consent to participate in the trial.

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Exclusion Criteria
  1. Previous radiotherapy in the head and neck region.
  2. Concomitant or previous malignancies, except uncomplicated basal cell carcinoma, early (T1-2 N0) squamous cell carcinoma of the skin with follow-up time of at least one year for squamous cell carcinomas, and except other cancer with a disease-free follow-up of at least three years
  3. Two or more synchronous primary HNSCC at time of diagnosis
  4. Nasopharyngeal cancer
  5. Sinonasal cancer
  6. Co-existing disease prejudicing survival (expected survival < three years).
  7. Pregnancy or lactation
  8. Psychiatric or addictive disorders or other medical conditions which in the view of the investigator might impair patient compliance
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Conventionally fractioned (standard) groupControl groupThis groups is treated with standard radiotherapy treatment: RT 2.0 Gy daily to final radiation dose 68.0 Gy or
HFX-RT groupHyperfractionated radiotherpyTreated with Hyperfractionated radiotherapy (HFX-RT): Gy twice daily (10 fractions/week) with final dose 83.0 Gy
Primary Outcome Measures
NameTimeMethod
Local tumour control after treatmentEvery three months for two years, then every 6 moths up to 5 years

Local tumour control after treatment with conventionally fractionated (standard) RT compared with hyperfractionated radiotherapy (HFX-RT)

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (11)

Gävle Hospital

🇸🇪

Gävle, Sweden

Sahlgrenska University Hospital

🇸🇪

Göteborg, Sweden

Jönköping Hospital

🇸🇪

Jönköping, Sweden

Karlstad Hospital

🇸🇪

Karlstad, Sweden

Linköping University hospital

🇸🇪

Linköping, Sweden

Lund University Hospital

🇸🇪

Lund, Sweden

Karolinska University Hospital

🇸🇪

Stockholm, Sweden

University Hospital

🇸🇪

Umeå, Sweden

Uppsala Accademical Hospital

🇸🇪

Uppsala, Sweden

Västmanlands Hospital Västerås

🇸🇪

Västerås, Sweden

Örebro University Hospital

🇸🇪

Örebro, Sweden

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